Qigong and Exercise Therapy for Low Back Pain in Adults | NCT00993980

Studies
Qigong and Exercise Therapy for Low Back Pain in Adults

NCT00993980

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jul 10, 2012Estimated

Enrollment

127Actual

Phase

Not Applicable

Conditions

Low Back Pain

Interventions

qigong
exercise therapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Oct 13, 2009

First Submission Date that Met QC Criteria

Oct 13, 2009

First Posted Date

Oct 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2012

Last Update Posted Date

Jul 10, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

127Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	qigong	Procedure: qigong
2	Active Comparator	exercise therapy	Procedure: exercise therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
qigong	Procedure	one therapy session once a week during three months, that is 12 therapy sessions altogether	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
average pain intensity during the last 7 days measured on a visual analogue scale (VAS)		baseline, 3, 6 and 12 months

Secondary Outcomes

Measure	Description	Time Frame
disability (Roland-Morris-Questionnaire RMQ)		baseline, 3, 6 and 12 months
health related quality of life (SF 36)		baseline, 3, 6 and 12 months
credibility of the therapy for patients

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of chronic low back pain since at least 3 months and complaints for a maximum duration of 5 years
low back pain more prominent than other pain in the spine
average pain intensity of the last 7 days more or equal to 40 mm measured by a visual analogue scale (VAS 0 - 100 mm)
intellectual and physical ability to participate in the study
informed consent

Exclusion Criteria:

low back pain related to malignancy
low back pain due to an accident
inflammatory joint disorders
previous spine surgery
protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology
actually doing or planning to do other regular physical exercise during the study with possible positive effects on low back pain - such as swimming, yoga, pilates, tai chi, etc.
planning to do another therapy during the study with possible positive effects in low back pain, such as physiotherapy, acupuncture, massage, spinal manipulation etc.
use of pain drugs for other diseases (> 1x/week)
pregnancy
severe chronic or acute disease interfering with therapy attendance
alcohol or substance abuse
participation in another clinical trial in the last 6 months before study entry

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudia M Witt, MD	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center		Berlin		10117	Germany

ID	Term
D017116	Low Back Pain

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Intervention Browse Module

MeSH Terms

ID	Term
D064906	Qigong
D005081	Exercise Therapy

Ancestor Terms

ID	Term
D001945	Breathing Exercises
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided